In general, In-Vitro Diagnostics (IVD) is a diagnosis technique of taking a body fluid as a specimen, such as blood, urine, excrement, spinal fluid, various tissues, gastric fluid, or synovial fluid, from a human body and making a diagnosis by optically detecting chemical properties using a reagent reacting to the specimen.
Typically, a clinic makes an in-vitro diagnosis by extracting a necessary specimen from a human body, post-processing the extracted specimen, for example, by cultivation or separation in a laboratory, and diagnosing the specimen through interpretation using a magnifying tool such as a microscope or other analysis tools by a tester having medical knowledge. This in-vitro diagnosis technique takes expensive equipment and many personnel, thus increasing cost.
The in-vitro diagnosis technique is used to make a diagnosis of a specific disease or evaluate the state of a patient in a clinic by taking a specimen from the patient and testing the specimen in the departments of diagnostic medicine and pathology.
Recently, a specific reagent chemically reacting to an extracted specimen has been developed and an in-vitro diagnosis has been made by optically analyzing features resulting from chemical reaction between the specimen and the reagent in some diagnostic tests.
In such an in-vitro diagnosis, a material such as blood or urine is taken as a specimen from a human body, mixed with a reagent causing chemical reaction according to the type of the specimen and a diagnosis purpose, and analyzed by means of an analyzer. The in-vitro diagnosis is used for diagnosis such as immunological diagnosis, clinical diagnosis, clinical microbiological diagnosis, tissue diagnosis, molecular diagnosis, self-blood sugar metering, in-situ testing, and hemostasis testing.
In the in-vitro diagnosis technique as described above, a specimen suitable for a test is selected from materials taken from a human body, such as blood and urine, mixed with a reagent prepared according to the specimen and a test method, absorbed with an analysis strip, and diagnosed by means of a diagnostic device such as a laser beam-based fluorescent diagnostic device.
In the conventional in-vitro diagnosis device, however, an operator manually introduces and mixes a specimen and a reagent using a manual suction tool, pipette. Therefore, the volumes of the specimen and the reagent are different according to the skill of the operator and a task state, thereby decreasing diagnostic reliability.
Moreover, the mixture of the specimen and the reagent is dropped on an analysis strip formed of an absorbing material, and an analysis should be made after a predetermined time over which the mixture is absorbed into the analysis strop. However, the volumes of the dropped specimen and reagent may differ according to the skill of the operator and the task state, and it may take a different time to absolve the mixture with the analysis strip. As a result, diagnostic reliability is decreased significantly.
Since the specimen has been taken from the human body and thus is vulnerable to contamination or component transform with the passage of time due to external factors such as temperature, foreign materials, and humidity, a diagnosis should be made rapidly. However, a manual diagnosis may suffer time delay and thus contamination or component transform of the specimen, thereby decreasing the accuracy of a diagnosis result.